Category Archives: Regulatory

On the May 9th issue of Information Week, Mitch Wagner provides some simple and elegant solutions on his article entitled “A Simple Fix For RFID Privacy”

In a previous article Levi Strauss proposal to use RFID tags on their Jeans was condemned by privacy advocates. He states “I’m not sure what the heck they’re worried about. I mean, how can you be concerned about privacy protection for information that’s already written on people’s butts?”

Although people may not be concerned about RFID tags in Levi’s Jeans, they ought to be concerned about RFID tags on prescription drugs.

The Food and drug administration (FDA) has issued a report recommending the widespread use of RFID technology throughout the pharmaceutical industry by 2007. The goal is to stem the tide of counterfeit drugs currently available though the internet.

RFID will play a key role in securing our nations drug supply. I can see a day were RFID tags will be the electronic equivalents of tamper proof seals, allowing consumers to rapidly identify counterfeit and fraudulent drugs.

However, there are significant privacy issues that must be addressed.

Would you want anyone with a rogue RFID reader finding out which prescription drugs you are taking?

A company is looking for a customer complaints/ CAPA system. They are considering Building it with MS Access or Buying an off the shelf product?

Are there any special issues with validating such a system compare to in MS Access?

Building FDA compliant applications on MS Access can be problematic. It is especially challenging to meet industry and FDA security requirements with Access as the back-end database.

From a compliance standpoint, building custom software requires you to develop all the documentation for you system from scratch. You must also perform unit, integration and system testing for the application before you move to the qualification of the system (all the Qs).

Compliant Management and CAPA are required by the FDA. As a result, there are a number of mature Commercial Off The Shelf (COTS) products widely used in the industry.

In this particular case I would recommend a BUY with two caveats:

First, make sure you assess and evaluate the vendor’s product to ensure it meets your business needs.

Second, you assess the supplier’s quality system and Life-Cycle practices to ensure they meet your standards. Make sure you perform this supplier assessment BEFORE you buy.

I started thinking, we want our clothes to be a good fit, why not our software applications?

How did we end up with one size fits all software?

In the Late 80’s computers began to appear on desktops in offices, labs and shop floors in Life-Sciences companies. Pretty soon servers had hatched under every department manager’s desk. These stand alone department servers run homegrown applications often developed in programs like Lotus123, FoxPro and Paradox. These applications were not always validated, and over time some grew to run entire departments. In the mid 90s Life-Science companies and the Regulators realized the extent of computerization in the industry. MIS departments were directed to take control over the IT infrastructure and bring order to the digital chaos.

The result was often the implementations of monolithic systems like MRP and LIMS. Although I believe that enterprise applications play a key role in today’s Life-Sciences Companies, experience has shown that “one size does NOT fit all”.

With the advent of Service Oriented Architectures and Web Services (what IBM used to call the universal business adaptor), it is now possible to seamlessly integrate best of breed applications that fit your business needs without increasing the total cost of ownership.

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